CO-TENIDONE 50/12.5 MG FILM-COATED TABLETS BP

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Co-tenidone 50/12.5 mg Film-coated Tablets BP
Co-tenidone 100/25 mg Film-coated Tablets BP
(atenolol and chlortalidone)
Read all of this leaflet carefully before you start taking this medicine because it
contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only. Do not pass it on to others. It
may harm them, even if their symptoms are the same as yours.
- If you get any side effects, talk to your doctor. This includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1. What Co-tenidone Tablets are and what they are used for
2. What you need to know before you take Co-tenidone Tablets
3. How to take Co-tenidone Tablets
4. Possible side effects
5. How to store Co-tenidone Tablets
6. Contents of the pack and other information
1. WHAT CO-TENIDONE TABLETS ARE AND WHAT THEY ARE USED FOR
Co-tenidone tablet is used to treat high blood pressure (hypertension). Co-tenidone
Tablets contain two active ingredients:
• atenolol belongs to a group of medicines called beta-blockers which help the heart
beat more slowly and with less force.
• chlortalidone belongs to a group of medicines called thiazide diuretics which remove
excess water and salt. It works by increasing the amount of urine produced by your
kidneys.
These tablets are prescribed for adults only. You must talk to a doctor if you do not feel
better or if you feel worse.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CO-TENIDONE TABLETS
Do not take Co-tenidone Tablets If you have:
• an allergy (hypersensitivity) to atenolol, chlortalidone or any of the other ingredients in
the medicine (listed in section 6).
• if you have ever had any of the following heart problems:
• heart failure which is not under control (this usually makes you breathless and
causes your ankles to swell).
• second or third degree heart block (irregular heartbeat) or cardiogenic shock
(shock caused by cardiac arrest).
• very slow or very uneven heart beats (bradycardia), very low blood
pressure (hypotension) or severe peripheral blood circulation problems (very
poor circulation) which may cause your fingers and toes to tingle or turn pale or
blue.
• severe kidney failure.
• sick sinus syndrome (heart conduction or rhythm problems).
• untreated phaeochromocytoma (high blood pressure due to a tumour near the
kidney).
• metabolic acidosis (an increased acidity of the blood).
• if you are pregnant, are trying to become pregnant or are breast-feeding.
Warnings and precautions
Talk to your doctor before taking Co-tenidone Tablets, if you have the following:
• have a tight, painful feeling in the chest in periods of rest (Prinzmetal's angina).
• have poor liver function/liver disease.
• intermittent claudication (episodic muscle pain or cramp when taking exercise).
• suffer from Raynauds syndrome (discoloration of the fingers,toes and occasionally
other areas).
• have a history of allergic reactions, as you may become more sensitive to allergens or
experience more serious allergic reactions.
• have a heart condition, first-degree heart block.
• have any breathing difficulties, in case of bronchospasm (tightening of muscles in
your airways). If you have ever had asthma or wheezing, do not take this medicine
without first checking with your doctor.
• are a diabetic or have abnormally low blood sugar levels - the amount of sugar in
your urine should be monitored with longer treatment. Your medicine may change
how you respond to having low blood sugar. You may feel your heart beating faster.

• are on a low potassium diet, have high blood potassium levels or an imbalance of
other electrolytes (salts) in your blood. Your fluid and electrolyte levels should be
regularly monitored during your treatment with this medicine.
• have gout or excess uric acid in your blood.
• are elderly.
• have poor blood circulation or controlled heart failure.
• have thyrotoxicosis (a condition caused by an overactive thyroid gland). Your
medicine may hide the symptoms of thyrotoxicosis.
• have problems with your adrenal glands.
Children
This medicine is not for use in children.
Other medicines and Co-tenidone tablets
Tell your doctor if you are taking or have recently taken any other medicines, including
those obtained without a prescription, particularly:
• if you are taking clonidine and Co-tenidone together, do not stop taking clonidine
unless your doctor tells you to do so. If you have to stop taking clonidine, your doctor
will give you careful instructions about how to do it.
• blood pressure lowering medicines (e.g. verapamil, nifedipine, diltiazem).
• disopyramide or amiodarone (for an uneven heart beat).
• digoxin (for heart problems).
• baclofen (a medicine used for muscle relaxation).
• ibuprofen (for pain and inflammation).
• adrenaline, used to treat shock, also known as epinephrine (a medicine that
stimulates the heart).
• insulin or medicines that you take by mouth for diabetes.
• lithium (used in the treatment of depression).
• certain medicines for arthritis or inflammation (e.g. indometacin).
• anaesthetics (patient should be advised to tell hospital staff if they are taking the
medicine and are due to have an operation).
• medicines to treat nose or sinus congestion or other cold remedies (including those
you can buy in the pharmacy).
• betaxolol, carteolol, levobunolol and timolol (eye drops for glaucoma).
Operations
If you go into hospital to have an operation, tell the anaesthetist or medical staff that you
are taking Co-tenidone. This is because you can get low blood pressure (hypotension). If
you are given certain anaesthetics while you are taking Co-tenidone.
Pregnancy and breast-feeding
Do not take Co-tenidone Tablets if you are pregnant or breast-feeding. Ask your doctor for
advice before taking any medicine.
Driving and using machines
Your medicine is not likely to affect you being able to drive or use any tools or machines.
However, it is best to wait to see how your medicine affects you before trying these
activities.
If you feel dizzy or tired when taking this medicine, ask your doctor for advice.
3. HOW TO TAKE CO-TENIDONE TABLETS
Always take Co-tenidone Tablets exactly as your doctor has told you. The pharmacist's
label should tell you how much to take and how often.
The tablets must be swallowed with a drink of water.
Dosage
• Adults - take one 50/12.5 mg tablet or one 100/25 mg tablet a day.
• Elderly or patients with kidney disease - your doctor may prescribe a reduced dose.
• Children - not recommended.
If you take more Co-tenidone Tablets than you should
If you accidentally take too many of these tablets, contact your doctor or nearest
accident and emergency department immediately (take any remaining medicine in its
original package with you if you can). Symptoms of overdose include a slow heart rate,
low blood pressure, nausea (feeling sick), weakness, dizziness and imbalance of
electrolytes.
If you forget to take Co-tenidone Tablets
If you miss a dose, take it as soon as you remember. If it is almost time for your next dose,
skip the forgotten dose and just carry on as before.
Do not take a double dose to make up for the one you have forgotten.

If you stop taking Co-tenidone Tablets
Do NOT stop taking Co-tenidone Tablets without seeking medical advice first.
If you have any further questions on the use of this medicine, ask your doctor or
pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Co-tenidone Tablets can cause side effects, although not everybody
gets them.
Allergic reactions:
If you have an allergic reaction, see a doctor straight away. The signs may include raised
lumps on your skin (weals) or swelling of your face, lips, mouth, tongue or throat.
Other possible side effects:
Common (may affect up to 1 in 10 people)
• Cold hands and feet.
• You may notice that your pulse rate becomes slower while you are taking the tablets.
This is normal, but if you are concerned please tell your doctor about it.
• Diarrhoea.
• Feeling sick (nausea).
• Feeling tired.
• Changes in the amount of certain substances in your blood. It can cause:
• higher levels of sugar (glucose) than normal.
• low levels of sodium, which may cause weakness, being sick (vomiting) and
cramps.
• low levels of potassium.
• an increase in the amount of uric acid.
Your doctor may take blood samples every so often to check on these levels.
Uncommon (may affect up to 1 in 100 people)
• Disturbed sleep.
• Increased level of liver enzyme.
Rare (may affect up to 1 in 1,000 people)
• Heart block (which can cause an abnormal heart beat, dizziness, tiredness or fainting).
• Numbness and spasm in your fingers which is followed by warmth and pain
(Raynaud’s disease).
• Dizziness (particularly when standing up).
• Headache.
• Feeling confused.
• Changes in personality (psychoses) or hallucinations.
• Mood changes.
• Nightmares.
• Dry mouth.
• Thinning of your hair.
• Dry eyes.
• Skin rash.
• Tingling of your hands.
• Disturbances of vision.
• Bruising more easily or purplish marks on your skin.
• Being unable to get an erection (impotence).
• Jaundice (causing yellowing of your skin or the whites of your eyes).
• Pancreatitis (inflammation of a large gland behind the stomach).
• A reduced number of white blood cells.
Very rare (may affect up to 1 in 10,000 people)
• Changes to some of the cells or other parts of your blood. Your doctor may take
blood samples every so often to check whether Co-tenidone has had any effect on
your blood.
Not known (frequency cannot be estimated from the available data)
• Constipation.
• Lupus-like syndrome (a disease where the immune system produces antibodies that
attacks mainly skin and joints).
Conditions that may get worse
If you have any of the following conditions, they may get worse when you start to take your
medicine.
This happens rarely affecting less than 1 in 1,000 people:
• Psoriasis (a skin condition).
• Being short of breath or having swollen ankles (if you have heart failure).
• Asthma or breathing problems.
• Poor circulation.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible
side effects not listed in this leaflet. You can also report side effects directly via the Yellow
Card Scheme Website: www.mhra.gov.uk/yellowcard. By reporting side effects you can
help provide more information on the safety of this medicine.
5. HOW TO STORE CO-TENIDONE TABLETS
Keep this medicine out of the sight and reach of children.
Do not use Co-tenidone Tablets after the expiry date which is stated on the label. The
expiry date refers to the last day of that month.
The tablets should be stored below 25°C in their original package, protected from light and
moisture.
Medicines should not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer required. These measures will help to
protect the environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Co-tenidone Tablets contain
The active ingredients are atenolol (50 or 100 mg) and chlortalidone (12.5 or 25 mg), per
tablet.
The other ingredients are maize starch, calcium hydrogen phosphate dihydrate,
microcrystalline cellulose, povidone K30, sodium starch glycolate (type A), and
magnesium stearate. The film coating consists of Hypromellose (E464), Titanium dioxide
(El71), Macrogol, Iron oxide red (E172), Iron oxide yellow (E172) and Iron oxide black
(E172).
What Co-tenidone Film-coated Tablets BP (Co-tenidone Tablets) look like and
contents of the pack
The 50/12.5 mg and 100/25 mg tablets are brownish pink, round, biconvex and
film-coated, marked CT/50 or CT/100 on one side.
They are available in blister packs of 28s, 30s, 56s and 60s (not all pack sizes may be
marketed).
Manufacturer:
Medreich Plc,
Warwick House, Plane Tree Crescent Feltham,
TW13 7HF, United Kingdom
Marketing Authorisation Holder:
Activase Pharmaceuticals Limited,
11 Boumpoulinas, 3rd floor,
P.C. 1060, Nicosia, Cyprus
This leaflet was last revised in 02/2017.
Co-tenidone 50/12.5 mg Film-coated Tablets BP PL 28444/0101
Co-tenidone 100/25 mg Film-coated Tablets BP PL 28444/0100

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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